Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1106-2011 | Spectrum Soft Central Venous Catheter Tray Minocyciine/Rifampin Antibiotic Impregnated... | Cook Incorporated | FOZ | ||
| Z-1105-2011 | Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/12cm... | Cook Incorporated | FOZ | ||
| Z-1104-2011 | Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/15cm... | Cook Incorporated | FOZ | ||
| Z-1103-2011 | Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/8cm, CUTLMY501JCCT... | Cook Incorporated | FOZ | ||
| Z-1102-2011 | Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/12cm... | Cook Incorporated | FOZ | ||
| Z-1101-2011 | Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/8cm, CUDLMY501JCCT... | Cook Incorporated | FOZ | ||
| Z-1100-2011 | Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/12cm... | Cook Incorporated | FOZ | ||
| Z-1099-2011 | Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/8cm... | Cook Incorporated | FOZ | ||
| Z-1098-2011 | Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double... | Cook Incorporated | FOZ | ||
| Z-1097-2011 | Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double... | Cook Incorporated | FOZ | ||
| Z-1096-2011 | Peripherally Inserted Central Venous Catheter Tray Silicone, CPICSY401HOPKINS0911 00... | Cook Incorporated | LJT | ||
| Z-0953-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage... | Stryker Corp. | FQH | ||
| Z-0952-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage... | Stryker Corp. | FQH | ||
| Z-0951-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage... | Stryker Corp. | FQH | ||
| Z-0950-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage... | Stryker Corp. | FQH | ||
| Z-0949-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage... | Stryker Corp. | FQH | ||
| Z-0948-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage... | Stryker Corp. | FQH | ||
| Z-0947-2011 | The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage... | Stryker Corp. | FQH | ||
| Z-0718-2011 | Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-0606-2011 | Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0... | Becton Dickinson & Co | LZP | ||
| Z-0171-2011 | Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile | Siemens Medical Solutions USA, Inc. | IZL | ||
| Z-3113-2011 | DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue... | Express Diagnostics Int'l., Inc. | JXN | ||
| Z-2579-2011 | XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create... | Elekta Limited | MUJ | ||
| Z-0819-2011 | Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile Product Code... | DePuy Spine, Inc. | LRP | ||
| Z-0818-2011 | Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code... | DePuy Spine, Inc. | LRP | ||
| Z-0817-2011 | Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile Product Code: 2883-90-000 The... | DePuy Spine, Inc. | LRP | ||
| Z-2897-2011 | Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems... | Canon Medical Systems USA, Inc. | IYN | ||
| Z-1548-2011 | The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in... | Physio Control, Inc. | MKJ | ||
| Z-0583-2011 | NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The... | Teco Diagnostics | KQO | ||
| Z-0582-2011 | McKesson Medical Surgical 107-101 Urine Analyzer, Catalog Number: 107-101 The Uritek... | Teco Diagnostics | KQO | ||
| Z-0581-2011 | Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip... | Teco Diagnostics | KQO | ||
| Z-0580-2011 | Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine... | Teco Diagnostics | KQO | ||
| Z-0579-2011 | Cole Taylor Marketing, Inc. CT-101 Urine Analyzer, Catalog Number: CT-101 The Uritek... | Teco Diagnostics | KQO | ||
| Z-0578-2011 | Cliawaived, Inc. CLIA-101 Urine Analyzer, Catalog Number: CLIA-101 The Uritek TC-101... | Teco Diagnostics | KQO | ||
| Z-0577-2011 | Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101... | Teco Diagnostics | KQO | ||
| Z-1952-2011 | ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500. | ArthroCare Corporation | MBI | ||
| Z-1592-2011 | Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including... | Straumann USA, LLC | LLZ | ||
| Z-1668-2011 | Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is... | Abbott Medical | GKZ | ||
| Z-2039-2011 | ***REF MCA7-2SB***2 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment... | The Anspach Effort, Inc. | HTT | ||
| Z-2038-2011 | ***REF MCA7-1SB*** 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment... | The Anspach Effort, Inc. | HTT | ||
| Z-2037-2011 | ***REF MCA7-15SB*** 1.5 mm Fluted Ball, 7.3 cm. Use with Micro Curved... | The Anspach Effort, Inc. | HTT | ||
| Z-2036-2011 | ***REF MCA5-2SB*** 2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment... | The Anspach Effort, Inc. | HTT | ||
| Z-2035-2011 | ***REF MCA5-15SB ***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment... | The Anspach Effort, Inc. | HTT | ||
| Z-2034-2011 | **REF MCA5-1SB*** 1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA)... | The Anspach Effort, Inc. | HTT | ||
| Z-0827-2011 | ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0826-2011 | 4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Siemens... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0335-2011 | Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A. Method of... | Medtronic Neuromodulation | LKK | ||
| Z-0334-2011 | Medtronic Intrathecal Catheter, 8731SC with sutureless connector. Method of... | Medtronic Neuromodulation | LKK | ||
| Z-0454-2011 | DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non Pyrogenic; Rx only;Integra... | Integra LifeSciences Corporation | GXQ | ||
| Z-0453-2011 | DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non Pyrogenic; Rx only;Integra... | Integra LifeSciences Corporation | GXQ |
